Potential Heart Failure Implant Receives $113 Million for Clinical Trial

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    CVRx, the manufacturer of the homeostasis implant, Barostim neo, has just received $113 million in financing to complete a clinical trial of its implant for the treatment of heart failure. The device has received a go-ahead from the FDA for Humanitarian Device Exemption and was accepted into the Expedited Access Pathway in November last year.

    The device, which works by stimulating the body’s neural baroreflex system, is implanted under the collarbone, helping regulate the blood flow. CVRx is using the neuromodulation performed by the implant for resistant hypertension and heart failure, which renders the heart incapable of pumping the required blood to support the body. This use of neuromodulation is in contrast to its more common purpose of treating pain.

    When the baroreflex is diseased, it fails to regulate blood flow. In such a scenario, the Barostim neo implant stimulates the baroreceptors in the wall of the carotid artery, which activates the baroreflex through afferent pathways of the autonomic nervous system. In response, the brain sends signals, resulting in modulation of the afferent pathways, thereby reducing the high blood pressure and easing the blood vessels. This results in a reduction in the heart rate.

    The company, CVRx, says that the device is compatible with rhythm management implants and can be switched on and off, which points towards the flexibility of the treatment offered by the device. The device ensures conformity to the relevant European health and safety standards, i.e. it is CE marked, for the treatment of heart failure and resistant hypertension, and can also potentially be used in the treatment of chronic renal diseases.

    The company stated that the financing for the Series G comes from equity ($93 million) while the remaining $20 million come from a new debt facility. The leading investor was Johnson & Johnson’s JJDC while the other existing investors like New Enterprise Associates and Ysios BioFund also invested.

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